Back to resultsSpectral Analysis of Bowel Sounds in Preterm Babies of Less Than 32 Weeks of Amenorrhea (WA) as Predictive Factor of Enterocolitis (BHAPE)
Primary Purpose
Bowel Sounds, Spectral Analysis, Necrotizing Enterocolitis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Recording of the bowel sounds
Sponsored by
About this trial
This is an interventional prevention trial for Bowel Sounds focused on measuring bowel sounds, spectral analysis, Necrotizing Enterocolitis, preterm babies
Eligibility Criteria
Inclusion Criteria:
- preterm babies of less than 32WA
Exclusion Criteria:
- preterm babies of more than 32WA,
- digestive congenital malformation
Sites / Locations
- CHU AmiensRecruiting
Outcomes
Primary Outcome Measures
variation of spectral analysis of bowel sounds (frequency in Hz) before and after enteral nutrition
establishing spectral analysis of bowel sounds
Secondary Outcome Measures
Full Information
NCT ID
NCT05544097
First Posted
September 6, 2022
Last Updated
September 19, 2022
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT05544097
Brief Title
Spectral Analysis of Bowel Sounds in Preterm Babies of Less Than 32 Weeks of Amenorrhea (WA) as Predictive Factor of Enterocolitis
Acronym
BHAPE
Official Title
Spectral Analysis of Bowel Sounds in Preterm Babies of Less Than 32 Weeks of Amenorrhea (WA) as Predictive Factor of Enterocolitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The recording or bowels is easy and cheap. The investigators wonder if these sounds are modified in babies with high risk of necrotizing enterocolitis. In this study, the investigators suggest to record and do a spectral analysis of 30 seconds of bowel sounds in preterm babies of less than 32WA before and after enteral nutrition, every day until the end of hospitalization. A spectral analysis will be made for each record to determine frequencies of the signal. The investigators will try to determine physiological frequencies and look for modifications in pathological situations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bowel Sounds, Spectral Analysis, Necrotizing Enterocolitis, Preterm Babies
Keywords
bowel sounds, spectral analysis, Necrotizing Enterocolitis, preterm babies
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Recording of the bowel sounds
Intervention Description
Recording of the bowel sounds before and after enteral feeding three times a week with an electronical stethoscope
Primary Outcome Measure Information:
Title
variation of spectral analysis of bowel sounds (frequency in Hz) before and after enteral nutrition
Description
establishing spectral analysis of bowel sounds
Time Frame
36 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
preterm babies of less than 32WA
Exclusion Criteria:
preterm babies of more than 32WA,
digestive congenital malformation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
André LOKOMBE-LEKE, DR
Phone
03 22 08 76 07
Email
leke.andre@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andre Leke, MD
Phone
(33)322087607
Email
leke.andre@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Pierre TOURNEUX, Pr
First Name & Middle Initial & Last Name & Degree
François MOREAU, Dr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Spectral Analysis of Bowel Sounds in Preterm Babies of Less Than 32 Weeks of Amenorrhea (WA) as Predictive Factor of Enterocolitis
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